Nausap 150 Iv 150 mg Lyophilised powder for solution for infusion

NAUSAP 150 IV, in combination with other anti-emetic medicines, is indicated for the prevention of acute (0 to 24 hours) and delayed (> 24 to 120 hours) nausea and vomiting associated with initial and repeat courses of:

• highly emetogenic cancer chemotherapy (see section 4.2).
• moderately emetogenic cancer chemotherapy (see section 4.2).

Posology

NAUSAP 150 IV for intravenous administration is a lyophilised pro-drug of aprepitant. NAUSAP 150 IV is administered on Day 1 as an infusion over 20 to 30 minutes initiated approximately 30 minutes prior to chemotherapy. NAUSAP 150 IV should be administered in conjunction with a corticosteroid and a 5-HT3 antagonist as specified in the tables below. The professional information for the co-administered 5-HT3 antagonist must be consulted prior to initiation of treatment with NAUSAP 150 IV.

Recommended dosing for the prevention of nausea and vomiting associated with highly emetogenic cancer chemotherapy

Highly Emetogenic Chemotherapy Regimen

**Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1 and in the morning on Days 2 through 4. Dexamethasone should also be administered in the evenings on Days 3 and 4. The dose of dexamethasone accounts for interactions.

Recommended dosing for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy

Moderately Emetogenic Chemotherapy Regimen

**Dexamethasone should be administered 30 minutes prior to chemotherapy treatment on Day 1. The dose of dexamethasone accounts for interactions.

General information

See section 4.5 for additional information on the administration of NAUSAP 150 IV with corticosteroids. Refer to the full professional information for co-administered anti-emetic medicines.

Special populations

Elderly (u2265 65 years) No dosage adjustment is necessary for the elderly.

Gender No dosage adjustment is necessary based on age, gender, race or Body Mass Index (BMI).

Renal impairment No dosage adjustment is necessary for patients with severe renal insufficiency (creatinine clearance < 30 ml/min) or for patients with end stage renal disease undergoing haemodialysis.

Hepatic impairment No dosage adjustment is necessary for patients with mild to moderate hepatic insufficiency (Child-Pugh score 5 to 9). There are no clinical data in patients with severe hepatic insufficiency (Child-Pugh score > 9) (see section 4.4).

Method of administration

NAUSAP 150 IV is administered by intravenous infusion over a 20 to 30-minute period. NAUSAP 150 IV should not be given by the intramuscular or subcutaneous route. For instructions on reconstitution/dilution of the medicine before administration, see section 6.6.

NAUSAP 150 IV is contraindicated in patients who are hypersensitive to aprepitant, polysorbate 80 or to any of the excipients listed in section 6.1. NAUSAP 150 IV should not be used concurrently with pimozide, terfenadine, astemizole or cisapride. Inhibition of cytochrome P450 isoenzyme 3A4 (CYP3A4) by aprepitant could result in elevated plasma concentrations of these medicines potentially causing serious or life-threatening reactions (see section 4.5).

Pregnancy and lactation (see section 4.6).

Paediatric use Safety and efficacy of NAUSAP 150 IV in paediatric patients have not been established.

Severe hepatic insufficiency Severe hepatic insufficiency (Child-Pugh score > 9). There are no clinical or pharmacokinetic data in patients with severe hepatic insufficiency. Caution should be exercised when NAUSAP 150 IV is administered in these patients.

CYP3A4 interactions Since NAUSAP 150 IV is rapidly converted to aprepitant (a weak to moderate inhibitor of CYP3A4), NAUSAP 150 IV should be used with caution in patients receiving concomitant medicines that are primarily metabolised through CYP3A4; some chemotherapy medicines are metabolised by CY3A4 (see section 4.5). Weak inhibition of CYP3A4 by NAUSAP 150 IV could result in elevated plasma concentrations of these concomitant medicines (see section 4.5).

Concomitant administration of NAUSAP 150 IV with strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, voriconazole, posaconazole nefazodone, telithromycin, troleandomycin, clarithromycin, ritonavir, nelfinavir) should be approached with caution. The effect of oral aprepitant on the pharmacokinetics of orally administered CYP3A4 substrates is greater than the effect of oral aprepitant on the pharmacokinetics of intravenously administered CYP3A4 substrates (see section 4.5).

Hypersensitivity Immediate hypersensitivity reactions including flushing, erythema, dyspnoea, and anaphylaxis/anaphylactic shock have occurred during or soon after infusion of NAUSAP 150 IV. These hypersensitivity reactions have generally responded to discontinuation of the infusion and administration of appropriate therapy. It is not recommended to re-initiate the infusion in patients who experience hypersensitivity reactions.

Warfarin Co-administration of NAUSAP 150 IV with warfarin may result in a clinically significant decrease in the prothrombin time or International Normalised Ratio (INR). In patients on chronic warfarin therapy, the International Normalised Ratio (INR) should be closely monitored in the 2 week period, particularly at 7 to 10 days following initiation of NAUSAP 150 IV with each chemotherapy cycle (see section 4.5).

Hormonal contraceptives The efficacy of hormonal contraceptives during and for 28 days after administration of NAUSAP 150 IV may be reduced. Alternative non-hormonal back-up methods of contraception should be used during treatment with NAUSAP 150 IV and for 1 month following the last dose (see section 4.5).

Use in the elderly In clinical studies, the efficacy and safety of aprepitant in the elderly (65 years and older) were comparable to those seen in younger patients (younger than 65 years). No dosage adjustment is necessary in elderly patients. (see section 4.2)

Administration and infusion site reactions Infusion site reactions (ISRs) have been reported with the use of NAUSAP 150 IV (see section 4.8). The majority of severe ISRs, including thrombophlebitis and vasculitis, were reported with concomitant vesicant (e.g., anthracycline-based) chemotherapy administration, particularly when associated with extravasation. Necrosis was also reported in some patients with concomitant vesicant chemotherapy. Mild injection site thrombosis has been observed at higher doses without concomitant vesicant chemotherapy. NAUSAP 150 IV should not be given as a bolus injection, but should always be diluted and given as a slow intravenous infusion (see section 4.2). IVEMEND should not be administered intramuscularly or subcutaneously. If signs or symptoms of local irritation occur, the injection or infusion should be terminated and restarted in another vein.

When administered intravenously, fosaprepitant is rapidly converted to aprepitant. Therefore, interactions following administration of NAUSAP 150 IV, are likely to occur with medicines that interact with oral aprepitant. Aprepitant is a substrate, a weak to moderate inhibitor and an inducer of CYP3A4. Aprepitant is also an inducer of CYP2C9. NAUSAP 150 IV, given as a single dose, is a weak inhibitor of CYP3A4, and thereby may increase the plasma concentrations of co-administered medicines that are metabolised through CYP3A4. It does not induce CYP3A4. It is anticipated that NAUSAP 150 IV would cause less or no greater induction of CYP2C9 than that caused by the administration of oral aprepitant (see u201cWarfarinu201d and u201cTolbutamideu201d below).

Aprepitant has been shown to induce the metabolism of S (-) warfarin and tolbutamide, which are metabolised through CYP2C9. Co-administration of NAUSAP 150 IV with these medicines or other medicines that are known to be metabolised by CYP2C9, such as phenytoin, may result in lower plasma concentrations of these medicines. NAUSAP 150 IV is unlikely to interact with medicines that are substrates for the P-glycoprotein transporter, as demonstrated by the lack of interaction of oral aprepitant with digoxin in a clinical interaction study.

The following information was derived from studies conducted with oral aprepitant and studies conducted with intravenous single-dose fosaprepitant co-administered with dexamethasone, midazolam, or diltiazem.

Effect of fosaprepitant on the pharmacokinetics of other active substances

CYP3A4 inhibition As a weak inhibitor of CYP3A4, the fosaprepitant 150 mg single dose can cause a transient increase in plasma concentrations of co-administered active substances that are metabolised through CYP3A4. The total exposure of CYP3A4 substrates may increase up to 2-fold on Days 1 and 2 after co-administration with a single 150 mg fosaprepitant dose. NAUSAP 150 IV must not be used concurrently with pimozide, terfenadine, astemizole, or cisapride. Inhibition of CYP3A4 by fosaprepitant could result in elevated plasma concentrations of these active substances, potentially causing serious or life-threatening reactions. (See section 4.3).

Caution is advised during concomitant administration of NAUSAP 150 IV and active substances that are metabolised primarily through CYP3A4 and with a narrow therapeutic range, such as cyclosporine, tacrolimus, sirolimus, everolimus, alfentanil, diergotamine, ergotamine, fentanyl, and quinidine (see section 4.4).

Corticosteroids Dexamethasone: NAUSAP 150 IV administered as a single intravenous dose on Day 1 increased the AUC 0-24hr of dexamethasone, a CYP3A4 substrate, by approximately 2,0 fold on Days 1 and 2 when dexamethasone was co-administered as a single 8 mg oral dose on Days 1, 2, and 3. The oral dexamethasone dose on Days 1 and 2 should be reduced by approximately 50 % when co-administered with NAUSAP 150 IV on Day 1 to achieve exposures of dexamethasone similar to those obtained when given without NAUSAP 150 IV (see section 4.2).

Methylprednisolone: Oral aprepitant, when given as a regimen of 125 mg on Day 1 and 80 mg/day on Days 2 and 3, increased the AUC of methylprednisolone, a CYP3A4 substrate, by 1,3-fold on Day 1 and by 2,5-fold on Day 3, when methylprednisolone was co-administered intravenously as 125 mg on Day 1 and orally as 40 mg on Days 2 and 3.

Chemotherapeutic medicines Interaction studies with fosaprepitant 150 mg and chemotherapeutic medicinal products have not been conducted; however, based on studies with oral aprepitant and docetaxel and vinorelbine, NAUSAP 150 IV is not expected to have a clinically relevant interaction with intravenously administered docetaxel and vinorelbine. Docetaxel: In a separate pharmacokinetic study, oral aprepitant, (CINV regimen) did not influence the pharmacokinetics of docetaxel. Vinorelbine: In a separate pharmacokinetic study, oral aprepitant, (CINV regimen) did not influence the pharmacokinetics of vinorelbine. An interaction with orally administered chemotherapeutic medicines metabolised primarily or partly by CYP3A4 (e.g. etoposide, vinorelbine) cannot be excluded. Caution and careful monitoring are advised in patients receiving etoposide, vinorelbine, docetaxel, ifosfamide, cyclophosphamide, irinotecan and paclitaxel or other chemotherapy agents metabolised primarily or partly by CYP3A4 (see section 4.4).

Post-marketing events of neurotoxicity, a potential adverse reaction of ifosfamide, have been reported after aprepitant and ifosfamide co-administration.

Immunosuppressants Following a single 150 mg fosaprepitant dose, a transient moderate increase for two days possibly followed by a mild decrease in exposure of immunosuppressants metabolised by CYP3A4 (e.g. cyclosporine, tacrolimus, everolimus and sirolimus) is expected. Given the short duration of increased exposure, dose reduction of the immunosuppressant based on Therapeutic Dose Monitoring is not recommended on the day of and the day after administration of NAUSAP 150 IV.

Midazolam NAUSAP 150 IV administered as a single intravenous dose on Day 1 increased the AUC 0-u221e of midazolam by approximately 1,8-fold on Day 1 and had no effect (1,0-fold) on Day 4 when midazolam was co-administered as a single oral dose of 2 mg on Days 1 and 4. NAUSAP 150 IV is a weak CYP3A4 inhibitor as a single dose on Day 1 with no evidence of inhibition or induction of CYP3A4 observed on Day 4. In addition, when NAUSAP 150 IV was administered as a dose of 100 mg over 15 minutes along with a single dose of midazolam 2 mg, the plasma AUC of midazolam was increased by 1,6-fold. This effect was not considered clinically important.

Oral aprepitant increased the AUC of midazolam, by 2,3-fold on Day 1 and 3,3 fold on Day 5, when a single oral dose of midazolam 2 mg was co-administered on Day 1 and Day 5 of a regimen of oral aprepitant 125 mg on Day 1 and 80 mg/day on Days 2 through 5.

The potential effects of increased plasma concentrations of midazolam or other benzodiazepines metabolised via CYP3A4 (alprazolam, triazolam) should be considered when co-administering these medicines with NAUSAP 150 IV.

Induction The fosaprepitant 150 mg single dose did not induce CYP3A4 on Days 1 and 4 in the midazolam interaction study. It is anticipated that NAUSAP 150 IV would cause less or no greater induction of CYP2C9, CYP3A4, and glucuronidation than that caused by the administration of the 3-day oral aprepitant regimen, for which a transient induction with its maximum effect 6-8 days after first aprepitant dose has been observed. The 3-day oral aprepitant regimen resulted in an about 30-35 % reduction in AUC of CYP2C9 substrates and up to a 64 % decrease in ethinyl estradiol trough concentrations. Data are lacking regarding effects on CYP2C8 and CYP2C19.

Caution is advised when warfarin, a cenocoumarol, tolbutamide, phenytoin or other active substances that are known to be metabolised by CYP2C9 are administered with NAUSAP 150 IV.

Warfarin A single 125 mg dose of oral aprepitant was administered on Day 1 and 80 mg/day on Days 2 and 3 to healthy subjects who were stabilised on chronic warfarin therapy. Although there was no effect of oral aprepitant on the plasma AUC of R(+) or S(-) warfarin determined on Day 3, there was a 34 % decrease in S(-) warfarin (a CYP2C9 substrate) trough concentration accompanied by a 14 % decrease in the prothrombin time [reported as International Normalised Ratio (or INR)] 5 days after completion of dosing with oral aprepitant. In patients on chronic warfarin therapy, the prothrombin time (INR) should be closely monitored in the 2-week period particularly at 7 to 10 days, following initiation of fosaprepitant with each chemotherapy cycle. Prothrombin time (INR) should be done more frequently while using NAUSAP 150 IV.

Tolbutamide Oral aprepitant, when given as 125 mg on Day 1 and 80 mg/day on Days 2 and 3, decreased the AUC of tolbutamide (a CYP2C9 substrate) by 23 % on Day 4, 28 % on Day 8 and 15 % on Day 15, when a single dose of tolbutamide 500 mg was administered orally prior to the administration of the 3-day regimen of oral aprepitant and on Days 4, 8 and 15.

Diabetic patients using tolbutamide should be monitored for glucose changes.

Oral contraceptives Aprepitant, when given once daily for 14 days as a 100 mg capsule with an oral contraceptive containing 35 mcg of ethinylestradiol and 1 mg of norethindrone, decreased the AUC of ethinylestradiol by 43 %, and decreased the AUC of norethindrone by 8 %. In another study, a single dose of an oral contraceptive containing ethinylestradiol and norethindrone was administered on Days 1 through 21 with oral aprepitant, given as a regimen of 125 mg on Day 8 and 80 mg/day on Days 9 and 10 with ondansetron 32 mg IV on Day 8 and oral dexamethasone given as 12 mg on Day 8 and 8 mg/day on Days 9, 10 and 11. In the study, the AUC of ethinylestradiol decreased by 19 % on Day 10 and there was much as a 64 % decrease in ethinylestradiol trough concentrations during Days 9 through 21. While there was no effect on oral aprepitant on the AUC of norethindrone on Day 10, there was as much as a 60 % decrease in norethindrone trough concentrations during Days 9 through 21. The efficacy of hormonal contraceptives during and for 28 days after administration of NAUSAP 150 IV may be reduced. Alternative non-hormonal back-up methods of contraception should be used during treatment with fosaprepitant or aprepitant and for 1 month following the last dose.

5-HT3 antagonists Interaction studies with fosaprepitant 150 mg and 5-HT3 antagonists have not been conducted. However, in clinical interaction studies, the oral aprepitant when given as regimen of 125 mg on Day 1 and 80 mg on Days 2 and 3, did not have clinically important effects on the pharmacokinetics of ondansetron, granisetron, or hydrodolasetron (the active metabolite of dolasetron). Therefore, there is no evidence of interaction with the use of fosaprepitant 150 mg and 5-HT3 antagonists.

Effect of other medicines on the pharmacokinetics of aprepitant NAUSAP 150 IV should be used with caution in patients receiving concomitant medicines, including chemotherapy medicines that are primarily metabolised through CYP3A4. Aprepitant is a substrate for CYP3A4; therefore, co-administration of NAUSAP 150 IV with medicines that inhibit CYP3A4 activity may result in increased plasma concentrations of aprepitant. Consequently, concomitant administration of NAUSAP 150 IV with strong CYP3A4 inhibitors (e.g. ketoconazole, itraconazole, voriconazole, posaconazole, nefazodone, troleandomycin, clarithromycin, telithromycin, ritonavir, nelfinavir) should be approached with caution. Because moderate CYP3A4 inhibitors (e.g. diltiazem) result in a 2-fold increase in plasma concentrations of aprepitant, concomitant administration should be approached with caution. Aprepitant is a substrate for CYP3A4; therefore, co-administration of NAUSAP 150 IV with medicines that strongly induce CYP3A4 activity (e.g. rifampicin, carbamazepine, phenytoin, phenobarbital) should be avoided as the combination may result in reduced plasma concentrations of aprepitant that may result in decreased efficacy of NAUSAP 150 IV. Concomitant administration of fosaprepitant with herbal preparations containing St. John's Wort (Hypericum perforatum) is not recommended.

Ketoconazole When a single 125 mg dose of oral aprepitant was administered on Day 5 of a 10-day regimen of 400 mg/day of ketoconazole, a strong CYP3A4 inhibitor, the AUC of aprepitant increased approximately 5-fold and the mean terminal half-life of aprepitant increased approximately 3-fold. Concomitant administration of fosaprepitant or aprepitant with strong CYP3A4 inhibitors should be approached cautiously.

Rifampicin When a single 375 mg dose of oral aprepitant was administered on Day 9 of a 14-day regimen of 600 mg/day of rifampicin, a strong CYP3A4 inducer, the AUC of aprepitant decreased approximately 11-fold and the mean terminal half-life decreased approximately 3-fold. Co-administration of fosaprepitant or aprepitant with medicines that induce CYP3A4 activity may result in reduced plasma concentrations and decreased efficacy.

Additional interactions Diltiazem: In patients with mild to moderate hypertension, infusion of 100 mg of fosaprepitant over 15 minutes with diltiazem 120 mg 3 times daily, resulted in a 1,5-fold increase of aprepitant AUC and a 1,4-fold increase in diltiazem AUC. The pharmacokinetic effects resulted in a clinically meaningful decrease in diastolic blood pressure (decrease of 16,8 mm Hg with fosaprepitant versus 10,5 mm Hg without fosaprepitant) and may result in a clinically meaningful decrease in systolic blood pressure (decrease of 24,4 mm Hg with fosaprepitant versus 18,8 mm Hg without fosaprepitant), but did not result in a clinically meaningful change in heart rate, or PR interval beyond those changes induced by diltiazem alone.

In the same study, administration of aprepitant once daily, as a tablet formulation comparable to 230 mg of the capsule formulation, with diltiazem 120 mg 3 times daily for 5 days, resulted in a 2-fold increase of aprepitant AUC and a simultaneous 1,7-fold increase of diltiazem AUC. These pharmacokinetic effects did not result in clinically meaningful changes in ECG, heart rate, or blood pressure beyond those changes induced by diltiazem alone.

Paroxetine Co-administration of once daily doses of aprepitant, as a tablet formulation comparable to 85 mg or 170 mg of the capsule formulation, with paroxetine 20 mg once daily, resulted in a decrease in AUC by approximately 25 % and C max by approximately 20 % of both aprepitant and paroxetine.

NAUSAP 150 IV is contraindicated in pregnancy and lactation. Contraception in males and females The efficacy of hormonal contraceptives may be reduced during and for 28 days after administration of NAUSAP 150 IV. Alternative non-hormonal back-up methods of contraception should be used during treatment with NAUSAP 150 IV and for 1 month following the last dose of NAUSAP 150 IV (see sections 4.4 and 4.5).

Pregnancy Safety in pregnancy and lactation has not been established.

Breast-feeding Mothers on treatment with NAUSAP 150 IV should not breastfeed their infants. Aprepitant is excreted in the milk of lactating rats. It is not known whether aprepitant is excreted in human milk.

Fertility The potential for effects of fosaprepitant and aprepitant on fertility has not been fully characterised because exposure levels above the therapeutic exposure in humans could not be attained in animal studies. These fertility studies did not indicate direct or indirect harmful effects with respect to mating performance, fertility, embryonic/foetal development, or sperm count and motility.

No studies of the effects of NAUSAP 150 IV on the ability to drive and use of machines have been performed. However, certain side effects that have been reported with NAUSAP 150 IV may affect some patientu2019s ability to drive or operate machinery. Dizziness and fatigue may occur following administration of NAUSAP 150 IV. Even though individual responses to NAUSAP 150 IV may vary, caution should be recommended when driving a car or operating machines (see section 4.8).

Since NAUSAP 150 IV is converted to aprepitant, those adverse experiences associated with aprepitant are also expected to occur with NAUSAP 150 IV. Oral aprepitant: Highly and Moderately Emetogenic Chemotherapy: The following adverse reactions were observed in a pooled analysis of the HEC and MEC studies at a greater incidence with oral aprepitant than with standard therapy or in postmarketing use.

Infections and infestations Less frequent: Candidiasis, staphylococcal infection

Blood and the lymphatic system disorders Less frequent: Anaemia, febrile neutropenia

Immune system disorders Frequency not known: Hypersensitivity reactions including anaphylactic reactions

Metabolism and nutrition disorders Frequent: Decreased appetite Less frequent: Polydipsia

Psychiatric disorders Less frequent: Anxiety, disorientation, euphoria

Nervous system disorders Frequent: Headache Less frequent: Dizziness, somnolence, cognitive disorder, lethargy, dysgeusia

Eye disorders Less frequent: Conjunctivitis

Ear and labyrinth disorders Less frequent: Tinnitus

Cardiac disorders Less frequent: Palpitations, bradycardia, cardiovascular disorder

Vascular disorders Less frequent: Hot flush /flushing

Respiratory, thoracic and mediastinal disorders Frequent: Hiccups Less frequent: Oropharyngeal pain, sneezing, cough, post-nasal drip, throat irritation

Gastrointestinal disorders Frequent: Constipation, dyspepsia Less frequent: Eructation, nausea, gastroesophageal reflux disease, vomiting, abdominal pain, dry mouth, flatulence, hard faeces, duodenal ulcer perforation, neutropenic colitis, stomatitis, abdominal distension

Skin and subcutaneous tissue disorders Less frequent: Rash, acne, photosensitivity reaction, hyperhidrosis, seborrhoea, skin lesion, pruritic rash, Stevens-Johnson syndrome/toxic epidermal necrolysis Frequency not known: Pruritus, urticaria

Musculoskeletal, connective tissue and bone disorders Less frequent: Muscle spasms, muscle weakness

Renal and urinary disorders Less frequent: Dysuria, polakiuria

General disorders and administration site conditions Frequent: Fatigue Less frequent: Asthenia, malaise, oedema, chest discomfort, gait disturbance

Investigations Frequent: Increased ALT Less frequent: Increased AST, increased blood alkaline phosphatase, increased urine output, positive red blood cells in urine, decreased blood sodium, decreased weight, glycosuria, decreased neutrophil count

Fosaprepitant: In an active-controlled clinical study in adult patients receiving highly emetogenic chemotherapy (HEC), safety was evaluated for 1 143 patients receiving the 1-day regimen of fosaprepitant 150 mg compared to 1 169 patients receiving the 3-day regimen of aprepitant. Additionally, in a placebo-controlled clinical trial in adult patients receiving moderately emetogenic chemotherapy (MEC), safety was evaluated for 504 patients receiving a single dose of fosaprepitant 150 mg compared to 497 patients receiving the control regimen. The safety profile was generally similar to that seen in the aprepitant studies as described above.

The following are adverse reactions reported in adult patients receiving fosaprepitant in clinical studies or postmarketing that have not been reported with oral aprepitant as described above. Infusion site reactions (ISRs) have been reported with the use of IVEMEND (see section 4.4) Vascular disorders Less frequent: Flushing, thrombophlebitis (predominantly, infusion site thrombophlebitis) Skin and subcutaneous tissue disorders Less frequent: Erythema General disorders and administration site conditions Less frequent: Infusion site erythema, infusion site pruritus, infusion site pain, infusion site induration Frequency not known: Immediate hypersensitivity reactions including flushing, erythema, dyspnoea, anaphylactic reactions/anaphylactic shock (see section 4.4). Investigations Less frequent: Increased blood pressure Other studies: Abdominal pain upper, bowel sounds abnormal, constipation*, dysarthria, dyspnoea, hypoaesthesia, insomnia, miosis, nausea, sensory disturbance, stomach discomfort, sub-ileus * , visual acuity reduced, wheezing * Reported in patients taking a higher dose of aprepitant

In the event of overdose, NAUSAP 150 IV should be discontinued and general supportive treatment and monitoring should be provided. Because of the antiemetic activity of aprepitant, emesis induced by a medicinal product may not be effective. Aprepitant cannot be removed by haemodialysis.